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Form 48B
Quality System Review Assessment Checklist
ISO/IEC 17025:15 MAY 2005
Revision 1
Instructions
Laboratory Accreditation Bureau (L-A-B) and its applicants for laboratory accreditation will use this document to conduct an ISO/IEC 17025:2005 Quality System Review, and as an assessment checklist during the assessment process. The clauses of ISO/IEC 17025 are paraphrased in this document, and do not necessarily reflect the complete requirements. The laboratory is required to prove compliance with the full requirements as stated in ISO/IEC 17025 in their entirety.
Applicant Laboratory
The applicant shall complete the column “Your Document” by referencing its document that shows they are compliant with the specific requirement. This is the only column that is to be filled out by the applicant. This reference should indicate the document name, page and paragraph(s) in which the compliance can be confirmed. This checklist and all documentation referenced on the checklist will then be forwarded to L-A-B Operations office.
Lead Assessor Document Review
The lead assessor is responsible for performing a document review using this checklist and references supplied to L-A-B by the laboratory. The lead assessor must confirm the documentation’s compliance with the requirements of ISO/IEC 17025, and indicate the laboratories compliance in the document compliance “C” and “N” columns of this form. The assessor will use the Doc Review / Pre Assessment Notes section to list any non-compliances or observations. The assessor should inform the client of any observations or requirements the laboratory may need to address prior to the assessment.
Lead Assessor Pre-assessment Visit (Optional)
The lead assessor will use this document to review each section and highlight areas which may be necessary for further review during the pre-assessment visit.
Lead Assessor Assessment Visit:
The lead assessor is responsible for completing this checklist by indicating the laboratory’
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